Many heart devices used in unqualified patients

CHICAGO Many people are getting implantable heart defibrillators who do not meet treatment guidelines, boosting costs of care and risks of complications, researchers said on Tuesday.

They said as many as 22.5 percent of so-called implantable cardioverter defibrillators or ICDs are put in people who do not meet treatment guidelines, either because they have recently had a heart attack or heart bypass surgery, or they have newly diagnosed or severe heart failure.

"The 22.5 percent rate is way too high and definitely much higher than what I had expected," said Dr. Sana Al-Khatib of the Duke Clinical Research Institute in Durham, North Carolina, whose study appears in the Journal of the American Medical Association.

ICDs detect dangerous heart rhythms and deliver a shock to restore normal heartbeats, protecting patients from sudden cardiac death in which the heart cannot pump blood.

People who have had a heart attack or those whose hearts are less efficient because of heart failure are at risk.

The devices are not recommended for use in people who have had a recent heart attack or who are still recovering from a heart bypass surgery, nor are they recommended in people with severe symptoms of heart failure, in which the heart struggles to pump blood.

Wall Street analysts said the findings might hurt sales of the devices. ICDs and pacemakers represent a global market of more than $10 billion for medical device makers such as Medtronic Inc, St. Jude Medical and Boston Scientific.

For the study, Al-Khatib and colleagues used a large national registry of ICD implants in patients covered by the federal Medicare insurance program for the elderly, but that also included a large number of private insurance patients.

The study looked only at ICD used to prevent sudden cardiac death and not the more costly devices that also include a pacemaker used to treat heart failure.

It showed out of more than 111,000 ICD implants between 2006 and 2009, 22.5 percent were done in patients who did not meet guidelines and might have been too sick to get the implants. Of these, 36.8 percent had had a heart attack within 40 days of the implant and 62.1 percent had been newly diagnosed with heart failure.

COMPLICATIONS

And patients who got an ICD without meeting treatment guidelines were more likely to die or develop a complication that prolonged their hospital stay.

Al-Khatib said the difference in the number of complications was modest -- and likely because those patients were sicker to start with -- but she said any harm is not worth the risk if there is no proof that patients will benefit.

The team also found that certain hospitals were more likely to follow guidelines than others, and they found that heart specialists known as electrophysiologists -- who specialize in implanting devices like ICDs and pacemakers -- were far more likely to follow treatment guidelines than other doctors who implant the devices.

The devices cost roughly $20,000 per implant.

"Instead of putting our money into procedures that are not likely to benefit patients, I'd rather see this money being used on procedures and devices that would help patients," Al-Khatib said.

She said other studies have found that many patients who do meet the guidelines for treatment are not getting them, and she hoped more money would be directed in ensuring those patients get treated.

Wells Fargo analyst Larry Biegelsen said in a note to clients the study could cut ICD sales by 18 percent if all off-label use of the devices were to disappear. But he did not think that was likely, largely because many patients who got the device too soon would eventually fit the guidelines.

Medtronic said in a statement it supports several trials now under way that will help identify patients who will benefit the most from the devices.

The company's shares fell less than 1 percent to $37.09, while shares of Boston Scientific tumbled 18 cents or 2.3 percent to $7.42 and St. Jude Medical fell $1.20, or nearly 3 percent to $41.08 in afternoon trading on the New York Stock Exchange.

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